Vast variation in inspection outcomes in India, China: US lawmakers question FDA

Three top American lawmakers have questioned the foreign drug inspection programme of the Food and Drug Administration in India and China.

In a letter to FDA Commissioner Robert Califf, the lawmakers on Monday (June 24) wrote that the difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA’s foreign drug inspection programme.

The letter dated June 21 was written by House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Subcommittee on Health Chair Brett Guthrie, and Subcommittee on Oversight and Investigations Chair Morgan Griffith following the analysis of the outcomes of FDA inspections in India and China from January 2014 to April 2024.

‘Surprising results’

“The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never found a single compliance issue throughout a combined 24 inspections in India,” they wrote.

Another inspector found zero compliance issues in 20 out of 23 inspections (85 per cent) in China while finding compliance issues in almost half of domestic inspections during the same period. These are unusual inspection outcomes, the opposite of what would be expected given the widely-reported failures in quality control and lack of adherence to current good manufacturing techniques by drug manufacturing facilities in China and India, the lawmakers wrote.

“By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted. As a measure of what a pattern of rigorous inspections should look like, the Committee reviewed the inspection outcomes for 3 FDA inspectors with a professional reputation for thoroughness who also had at least 10 inspections in China or India during the studied period,” they wrote.

Vast differences in competence of inspectors

These expert inspectors reported finding no compliance issues during inspections in China at a rate of only 6.7 to 11.4 per cent and at a rate of zero to 9.5 per cent in India, they said, adding that such large variations in inspection outcomes are troubling, and they merit further investigation. At a minimum, the Committee is concerned that these findings suggest vast differences in the skill, thoroughness, and competence of FDA inspectors.

As such, the lawmakers pressed for more information regarding the agency’s foreign drug inspection programme.

(With inputs from agencies)